ALBUTREPENONACOG ALFA

U.S. Department of Health & Human Services Divider Arrow

National Institutes of Health Divider Arrow

NCATS

US Approved Rx (2016)

First approved in 2016

Approval Year

Substance Class	Protein Created by `admin` on `Mon Mar 31 22:08:12 GMT 2025` Edited by `admin` on `Mon Mar 31 22:08:12 GMT 2025`
Protein Sub Type
Sequence Type	COMPLETE
Record UNII	A57KX1VL5P
Record Status	`Validated (UNII)`
Record Version

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Name

Type

Language

ALBUTREPENONACOG ALFA

Official Name

English

albutrepenonacog alfa [INN]

Preferred Name

English

IDELVION

Brand Name

English

Albutrepenonacog alfa [WHO-DD]

Common Name

English

CSL-654

Code

English

ALBUTREPENONACOG ALFA [MI]

Common Name

English

CSL654

Common Name

English

ALBUTREPENONACOG ALFA [JAN]

Common Name

English

COAGULATION FACTOR IX (RECOMBINANT), ALBUMIN FUSION PROTEIN

Common Name

English

Classification Tree Code System Code

FDA ORPHAN DRUG

366712

Created by admin on Mon Mar 31 22:08:12 GMT 2025 , Edited by admin on Mon Mar 31 22:08:12 GMT 2025

EMA ASSESSMENT REPORTS

INDELVION (AUTHORIZED: HEMOPHILIA B)

Created by admin on Mon Mar 31 22:08:12 GMT 2025 , Edited by admin on Mon Mar 31 22:08:12 GMT 2025

EU-Orphan Drug

EU/3/09/723

Created by admin on Mon Mar 31 22:08:12 GMT 2025 , Edited by admin on Mon Mar 31 22:08:12 GMT 2025

Code System Code Type Description

DAILYMED

A57KX1VL5P

Created by admin on Mon Mar 31 22:08:12 GMT 2025 , Edited by admin on Mon Mar 31 22:08:12 GMT 2025

PRIMARY

NCI_THESAURUS

C171813

Created by admin on Mon Mar 31 22:08:12 GMT 2025 , Edited by admin on Mon Mar 31 22:08:12 GMT 2025

PRIMARY

FDA UNII

A57KX1VL5P

Created by admin on Mon Mar 31 22:08:12 GMT 2025 , Edited by admin on Mon Mar 31 22:08:12 GMT 2025

PRIMARY

EVMPD

SUB174139

Created by admin on Mon Mar 31 22:08:12 GMT 2025 , Edited by admin on Mon Mar 31 22:08:12 GMT 2025

PRIMARY

SMS_ID

100000160835

Created by admin on Mon Mar 31 22:08:12 GMT 2025 , Edited by admin on Mon Mar 31 22:08:12 GMT 2025

PRIMARY

DRUG CENTRAL

5189

Created by admin on Mon Mar 31 22:08:12 GMT 2025 , Edited by admin on Mon Mar 31 22:08:12 GMT 2025

PRIMARY

CAS

1357448-54-4

Created by admin on Mon Mar 31 22:08:12 GMT 2025 , Edited by admin on Mon Mar 31 22:08:12 GMT 2025

PRIMARY

RXCUI

1743992

Created by admin on Mon Mar 31 22:08:12 GMT 2025 , Edited by admin on Mon Mar 31 22:08:12 GMT 2025

PRIMARY

MERCK INDEX

m12111

Created by admin on Mon Mar 31 22:08:12 GMT 2025 , Edited by admin on Mon Mar 31 22:08:12 GMT 2025

PRIMARY

DRUG BANK

DB13884

Created by admin on Mon Mar 31 22:08:12 GMT 2025 , Edited by admin on Mon Mar 31 22:08:12 GMT 2025

PRIMARY

INN

9700

Created by admin on Mon Mar 31 22:08:12 GMT 2025 , Edited by admin on Mon Mar 31 22:08:12 GMT 2025

PRIMARY

From	To
1_18	1_23
1_51	1_62
1_56	1_71
1_73	1_82
1_88	1_99
1_95	1_109
1_111	1_124
1_132	1_289
1_206	1_222
1_336	1_350
1_361	1_389
1_486	1_495
1_508	1_524
1_523	1_534
1_557	1_602
1_601	1_610
1_633	1_679
1_678	1_686
1_698	1_712
1_711	1_722
1_749	1_794
1_793	1_802
1_825	1_871
1_870	1_881
1_894	1_910
1_909	1_920
1_947	1_992
1_991	1_1000

Glycosylation Link Type	Site
N	1_157
N	1_167
O	1_53
O	1_61

Related Record Type Details


					6U90Y1795T

COAGULATION FACTOR IX HUMAN

TARGET->ENZYME REPLACEMENT

Amount:

Related Record Type Details


					A57KX1VL5P

ALBUTREPENONACOG ALFA

ACTIVE MOIETY

Structural Modifications

Modification Type	Location Site	Location Type	Residue Modified	Extent	Fragment Name	Fragment Approval
amino acid substitution	[1_64]		Aspartic acid		.BETA.-HYDROXY-L-ASPARTIC ACID, THREO-	Z9Q5W0U8VW
amino acid substitution	[1_7] [1_8] [1_15] [1_17] [1_20] [1_21] [1_26] [1_27] [1_30] [1_33] [1_36] [1_40]		GLUTAMIC ACID		.GAMMA.-CARBOXYGLUTAMIC ACID	16FQV4RZKL
amino acid substitution	[1_158]		SERINE		DEXFOSFOSERINE	VI4F0K069V
amino acid substitution	[1_155]		TYROSINE		TYROSINE O-SULFATE	29166358BF

Name	Property Type	Amount	Referenced Substance	Defining	Parameters	References
Molecular Formula	CHEMICAL
MOL_WEIGHT:NUMBER(CALCULATED)	CHEMICAL